Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices 85295 

II. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

draft guidance contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: December 1, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26845 Filed 12–6–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–3462] 

Verification Systems Under the Drug 

Supply Chain Security Act for Certain 

Prescription Drugs; Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Verification Systems Under the Drug 

Supply Chain Security Act for Certain 

Prescription Drugs.’’ The guidance 

addresses the verification systems that 

manufacturers, repackagers, wholesale 

distributors, and dispensers must have 

in place to comply with the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act), as amended by the Drug Supply 

Chain Security Act (DSCSA). 

Specifically, the guidance covers the 

statutory verification systems 

requirements that include the 

quarantine and investigation of a 

product determined to be suspect and 

the quarantine and disposition of a 

product determined to be illegitimate. 

The guidance also addresses the 

statutory requirement for notification to 

the Agency of a product that has been 

cleared by a manufacturer, repackager, 

wholesale distributor, or dispenser (also 

referred to as ‘‘trading partners’’) after a 

suspect product investigation because it 

is determined that the product is not an 

illegitimate product. Finally, the 

guidance addresses the statutory 

requirement for responding to requests 

for verification and processing saleable 

returns. The guidance finalizes the 

revised draft guidance ‘‘Verification 

Systems Under the Drug Supply Chain 

Security Act for Certain Prescription 

Drugs,’’ issued on March 10, 2022. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 7, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–D–3462 for ‘‘Verification Systems 

Under the Drug Supply Chain Security 

Act for Certain Prescription Drugs; 

Guidance for Industry; Availability.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https:// 

www.govinfo.gov/content/pkg/FR-2015-

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or to Office of Communication, 

Outreach and Development, Center for 


ddrumheller on DSK120RN23PROD with NOTICES1
85296 Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Sarah Venti, Office of Compliance, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–3130, drugtrackandtrace@

fda.hhs.gov; or Anne Taylor, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Verification Systems Under the Drug 

Supply Chain Security Act for Certain 

Prescription Drugs.’’ The DSCSA (title II 

of Pub. L. 113–54) was signed into law 

on November 27, 2013. Section 202 of 

the DSCSA added section 582 to the 

FD&C Act (21 U.S.C. 360eee–1), which 

established the requirement that trading 

partners have systems in place to enable 

them to comply with certain verification 

obligations. This guidance provides 

recommendations for robust verification 

systems for the determination, 

quarantine, and investigation of suspect 

products, as well as the quarantine, 

notification, and disposition of 

illegitimate products. This guidance 

also addresses the manner in which 

FDA recommends that trading partners 

submit cleared product notifications 

(i.e., notifications that a suspect product 

is not an illegitimate product), the 

statutory requirements for responding to 

requests for verification, and the 

statutory requirements for processing 

saleable returns. 

FDA initially published the draft 

guidance ‘‘Verification Systems Under 

the Drug Supply Chain Security Act for 

Certain Prescription Drugs’’ on October 

25, 2018 (83 FR 53880). Comments were 

received on the initial draft guidance 

and the Agency made revisions to the 

draft. This guidance finalizes the 

revised draft guidance entitled 

‘‘Verification Systems Under the Drug 

Supply Chain Security Act for Certain 

Prescription Drugs,’’ issued on March 

10, 2022 (87 FR 13738). FDA considered 

comments received on the revised draft 

guidance in finalizing this guidance. 

Changes from the revised draft to the 

final guidance include: (1) clarifying 

that dispensers need not provide 

transaction information for saleable 

return product; (2) clarifying that 

‘‘verification’’ as defined in section 581 

of the FD&C Act (21 U.S.C. 360eee) 

involves confirming that the product 

identifier affixed or imprinted upon a 

package or homogeneous case 

corresponds to the Standardized 

Numerical Identifier or lot number and 

expiration date assigned to the product 

by the manufacturer or repackager by 

more closely mirroring the statutory 

language; (3) further clarifying when the 

discussion is about the verification 

systems requirements in section 582 of 

the FD&C Act and when it is about the 

requirement to verify the product 

identifier; (4) clarifying FDA’s 

understanding about the statutory 

requirement that manufacturers and 

repackagers respond to requests for 

verification within 24 hours or within 

other such reasonable time as 

determined by the Secretary of Health 

and Human Services; (5) clarifying that 

when a trading partner does not receive 

a timely response to a verification 

request, the product that is the subject 

of the request need not automatically be 

classified as suspect; and (6) clarifying 

that certain system attributes are 

suggested as best practices even though 

they are not specifically required under 

the DSCSA. In addition, editorial 

changes were made to improve clarity. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Verification 

Systems Under the Drug Supply Chain 

Security Act for Certain Prescription 

Drugs.’’ It does not establish any rights 

for any person and is not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information pertaining to 

implementation of the Drug Supply 

Chain Security Act are approved in 

OMB control no. 0910–0806. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ 

biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: December 1, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26846 Filed 12–6–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–3517] 

Interim Policy on Compounding Using 

Bulk Drug Substances Under Section 

503A of the Federal Food, Drug, and 

Cosmetic Act; Draft Guidance for 

Industry; Availability. 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Interim 

Policy on Compounding Using Bulk 

Drug Substances Under section 503A of 

the Federal Food, Drug, and Cosmetic 

Act’’ (draft guidance or 2023 503A 

Interim Policy Draft Guidance) to 

describe FDA’s interim policy regarding 

the use of bulk drug substances by 

human drug compounders that are not 

registered with FDA as outsourcing 

facilities while FDA develops the list of 

bulk drug substances that can be used 

in compounding under the applicable 

section of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act). This draft 

guidance, when finalized, will replace 

the guidance for industry entitled, 

‘‘Interim Policy on Compounding Using 

Bulk Drug Substances under section 

503A of the Federal Food, Drug, and 

Cosmetic Act’’ issued in January 2017 

(2017 503A Interim Policy Guidance). 

DATES: Submit either electronic or 

written comments on the draft guidance 

by January 8, 2024 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 


ddrumheller on DSK120RN23PROD with NOTICES1